New Delhi, January 12
In less than three months since it flagged the Sonepat-based Maiden Pharma products as sub-standard and unsafe, the WHO on Wednesday night issued a global medical alert naming two cough syrups manufactured by Noida-based Marion Biotech.
The firm was previously shut for operations by the Indian drug regulator after Uzbekistan flagged children’s deaths after consumption of these medicines in higher-than-prescribed doses format.
The latest WHO Medical Product Alert refers to two sub-standard (contaminated) products, identified in Uzbekistan and reported to WHO on December 22, 2022.
Sub-standard medical products are products that fail to meet quality standards or specifications and are, therefore, “out of specification”.
The two products are Ambronol syrup and DOK-1 Max syrup. The stated manufacturer of both products is Marion Biotech Private Limited, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants,” the WHO said.
It said both these products may have marketing authorisations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions.
Accordingly, the WHO has asked the nations to recall the products.
The sub-standard products referenced in this latest alert, the WHO said, “are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death”.
In advice to regulatory authorities and the public, the WHO said it is important to detect and remove these sub-standard products from circulation to prevent harm to patients.
India has sampled the allegedly contaminated products from the Noida firm and reports of the lab tests are awaited.